FDA Highlights Systemic Issues at Mylan Laboratories in Recent Warning
FDA warns Mylan Laboratories for critical cGMP violations in quality control, data integrity, and governance, urging urgent corrective actions to ensure compliance.
FDA Transitional Enforcement Guidance for Ethylene Oxide Sterilization Facility Changes for Class III Devices
FDA announces a new policy on ethylene oxide sterilization site changes for Class III devices, ensuring supply chain stability and patient safety.